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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

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THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM Back to Search Results
Model Number 106524US
Device Problem Power Problem (3010)
Patient Problems Death (1802); Complaint, Ill-Defined (2331)
Event Date 12/20/2017
Event Type  Death  
Manufacturer Narrative
The initial submission of this event was reported by the manufacturer under mfr.Report # 2916596-2018-00466.This report is being submitted as additional information.The serial number was not provided, therefore the catalog number expiration date, device unique identifier (udi), and device manufacture date are not available.Approximate age of device ¿ 14 days.Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas and the reported events could not be conclusively established through this evaluation.The heartmate 3 lvas ifu lists death as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.
 
Event Description
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported that the patient expired.An autopsy was performed; the results were not provided.The pump was explanted (b)(6) 2017.Additional information was requested.
 
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Brand Name
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
Type of Device
LEFT VENTRICULAR ASSIST SYSTEM
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key8201374
MDR Text Key131580050
Report Number2916596-2018-05756
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024013297
UDI-Public00813024013297
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/05/2019
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number6174608
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/12/2018
Initial Date FDA Received12/27/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age75 YR
Patient Weight68
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